All documents shown here are included in the seminar for instant
download

We include our 10 most frequently ordered laboratory related SOPs in the
seminar for easy and compliant implementation.

We include our 20 most frequently ordered laboratory related forms in
the seminar for easy and compliant implementation

FDA Presentation:

Laboratory Inspections

Learn from FDA Warning Letters what inspectors look for and what
mistakes other companies make so you can avoid them

Links to GMP regulations and guidelines with impact on Quality Control
Laboratories

US FDA, EU, PIC/S, WHO, ICH

Labcompliance On-line Audio Seminar

This seminar has been recorded and is
available on CD and for instant download. All reference material as
listed below and more is available on a special seminar website. The
website is regularly updated with most recent information. In case
there are questions related to the topic, they can be submitted
through a web form and will be answered by the speaker. For ordering
info
click here
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On-line Audio Seminar 287

Laboratories supporting API and drug development and manufacturing have to
comply with FDA's and/or international GxP regulations. While such regulations
have been in place since a long time and do not change very often, guidance
documents, industry practices and enforcement practices do. What was enough
yesterday, is not any more today and even less tomorrow. This is proven by the
large number of recent FDA warning letters going to laboratories So the
industry has lots of questions on how to comply most efficiently.

Key Questions related to GMP compliance in QC laboratories:

What are the real essential requirements for laboratories?

What is FDA's focus during inspections?

Where does the industry have most problems to comply?

What are the best industry practices to comply?

Where and how can we really save costs?

Which procedures do we need?

How to keep up with ever changing FDA inspection practices
and surprises?

Once we have achieved compliance, how can we maintain it?

How to prepare for an FDA or EU inspection?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new
interactive audio seminar. During the seminar, the speaker will
present strategies and give practical recommendations. After the
seminar, an extensive list of reference material like master plans,
SOPs, templates and examples will help immediate and cost effective
implementation.

During the interactive presentation you learn about:

FDA and international regulations and guidelines

Recent examples of FDA warning letters related to
laboratories

GxP regulations along the drug life: development and
manufacturing?

Compliance along the laboratory workflow: from sampling to
data arching

Going through eight essential steps to achieve compliance

Cost savings through risk based compliance

Savings through inspection ready documentation

Savings through leveraging supplier support

Maintaining the laboratory compliance

Preparation for FDA inspections

Recommendations for implementation

And for easy and instant implementation:
download 20+ documents from special seminar website
Attendees have access to the seminar reference web site for at least
two years for on-going updf

Please forward to your colleagues

About audio seminars

Online audio seminars are presented over the
phone. During the live presentation attendees can:

Study the printed slide material

Watch the slides on a computer

Watch the slides on a video screen in a seminar room

Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been
conducting over 300 web and audio or video based seminars since 15 years and and
he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and
Validation around the world. This included seminars, workshops and presentations
for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health
agencies.

Dr. Ludwig Huber
is a frequent presenter at IVT conferences and has been
awarded as the 'Presenter of the Year' out of 170 speakers.
This photo is from IVT's conference on Network Qualification
with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and
compliance, for example: Validation of Computerized Analytical and
Networked Systems. He was or still is a member of several
committees, e.g., of the GAMP® Special
interest group (SIG) on Laboratory Computers, PDA Part 11 task
force, IVT task force on network infrastructure qualification and
the European Compliance Academy. He frequently visited FDA in
Rockville, VA, and participated in panel discussions with FDA
professionals. For feedback from attendees of seminars and for
other information on Dr. Ludwig Huber,
click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith,
FDA's national Part11 expert, at a panel discussion with
Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about
computer system validation and e-records.